National Alert System for Critical Antimicrobial Resistances (CARAlert) - Standard Operating Procedures
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D20-22112 National Alert System for Critical Antimicrobial Resistances (CARAlert) Standard Operating Procedures 2021 June 2021
Published by the Australian Commission on Safety and Quality in Health Care Level 5, 255 Elizabeth Street, Sydney NSW 2000 Phone: (02) 9126 3600 Fax: (02) 9126 3613 Email: CARAlert@safetyandquality.gov.au Website: www.safetyandquality.gov.au ISBN: 978-1-925948-52-3 © Australian Commission on Safety and Quality in Health Care 2021 All material and work produced by the Australian Commission on Safety and Quality in Health Care is protected by copyright. The Commission reserves the right to set out the terms and conditions for the use of such material. As far as practicable, material for which the copyright is owned by a third party will be clearly labelled. The Australian Commission on Safety and Quality in Health Care has made all reasonable efforts to ensure that this material has been reproduced in this publication with the full consent of the copyright owners. With the exception of any material protected by a trademark, any content provided by third parties, and where otherwise noted, all material presented in this publication is licensed under a Creative Commons Attribution–NonCommercial–NoDerivatives 4.0 International licence. Enquiries about the licence and any use of this publication are welcome and can be sent to communications@safetyandquality.gov.au. The Commission’s preference is that you attribute this publication (and any material sourced from it) using the following citation: Australian Commission on Safety and Quality in Health Care. National Alert System for Critical Antimicrobial Resistances (CARAlert): Standard Operating Procedures. Sydney: ACSQHC; 2021 Disclaimer The content of this document is published in good faith by the Australian Commission on Safety and Quality in Health Care for information purposes. The document is not intended to provide guidance on particular healthcare choices. You should contact your healthcare provider on particular healthcare choices. The Commission does not accept any legal liability for any injury, loss or damage incurred by the use of, or reliance on, this document. CARAlert standard operating procedures 2
Contents Introduction ........................................................................................................................ 4 Scope of this document .................................................................................................. 4 CARAlert processes ........................................................................................................... 5 Critical antimicrobial resistances reported through CARAlert .......................................... 6 Intended use of data collected through CARAlert ............................................................ 6 Roles and responsibilities of stakeholders who provide data to CARAlert........................... 8 Originating laboratories ................................................................................................... 8 Confirming laboratories ................................................................................................... 8 Roles and responsibilities of state and territory contacts with designated access to data from the CARAlert system ................................................................................................ 10 Roles and responsibilities of other users of data from the CARAlert system ..................... 11 Clinicians ...................................................................................................................... 11 Health services ............................................................................................................. 11 Roles and responsibilities of the CARAlert manager – the Australian Commission on Safety and Quality in Health Care .................................................................................... 12 Appendix 1 – CARAlert confirming laboratories, 2021 ...................................................... 13 Appendix 2 – CARAlert alert process ............................................................................... 14 CARAlert standard operating procedures 3
Introduction The National Alert System for Critical Antimicrobial Resistances (CARAlert) was established by the Australian Commission on Safety and Quality in Health Care (the Commission) in March 2016 as part of the development of the Antimicrobial Use and Resistance in Australia (AURA) Surveillance System. CARAlert collects data on nationally agreed priority organisms with critical resistance to last-line antimicrobial agents. It is an important element of informing early response capability for states and territories. While critical antimicrobial resistances (CARs) have historically occurred in low numbers in Australia, overseas experience has shown that they can result in significant morbidity in healthcare facilities and in the community. The most prominent examples of critical resistances are carbapenemase-producing Enterobacterales and vancomycin-nonsusceptible Staphylococcus aureus. The Commission established CARAlert to provide timely advice to state and territory health authorities on the occurrence of CARs in their hospitals and communities; to provide a national picture of CARs, which are an important component of overall resistance in Australia; and, to provide standardised guidance on processes for confirming CARs. Although some data on CARs are captured through local surveillance programs, where these exist, the CARAlert system is the first nationally coordinated system that supports both collection and communication of information on confirmed CARs and potential CAR outbreaks, as close as possible to the time of confirmation. Each state and territory health authority has nominated staff who are authorised to access the CARAlert system, via a web portal, to review CAR records for their state or territory. In addition to this direct access, information on confirmed CARs reported to CARAlert is disseminated to authorised state and territory staff by email via a Weekly Summary. Scope of this document This document provides an overview of the protocols and procedures relating to the operation of CARAlert and describes the roles and responsibilities of key stakeholders involved with the system. Further detail about the CARAlert system can be found in the CARAlert Laboratory Handbook.1 Reports and analyses of data collected through the CARAlert system are provided on the Commission’s AURA website. 1 Australian Commission on Safety and Quality in Health Care. CARAlert Laboratory Handbook. Sydney: ACSQHC; 2019. CARAlert standard operating procedures 4
CARAlert processes The CARAlert system is based on routine processes used by pathology laboratories for identifying and confirming potential CARs: Collection and routine testing – the specimen is collected from the patient and sent to the originating laboratory for routine testing. Isolates from routine culture considered to be pathogens undergo antimicrobial susceptibility testing. Confirmation – if the originating laboratory considers that the isolate is a possible CAR based on the results of antimicrobial susceptibility testing, it sends the isolate to a confirming laboratory that has the testing capacity to confirm the CAR. The confirming laboratory advises the originating laboratory of the result of the test, and the originating laboratory reports back to the health service or practitioner visited by the patient from whom the specimen was collected. Submission to the CARAlert system - the confirming laboratory submits the details of the resistance and organism into the secure CARAlert web portal at the same time as, or shortly after, communication with the health service attended by the patient. No patient-level data are submitted to, or held in the CARAlert system. Authorised officers in each state and territory health department can access the CARAlert web portal directly for further information about their jurisdiction, including the name of the public hospital where a patient with a confirmed CAR was cared for, and to extract reports on their data. Information about whether cases originated in aged care settings or in the community is also available. Public and private pathology laboratories that have the capacity to confirm CARs have been identified through consultation with state and territory health authorities, the Public Health Laboratory Network and the Australian Group on Antimicrobial Resistance. As at April 2021, there are 28 confirming laboratories participating in CARAlert (see Appendix 1). The CARAlert system generates a weekly summary report on confirmed CARs, which is provided by email to nominated personnel in the states and territories, the Australian Government Department of Health and the confirming laboratories. The weekly summary includes the following information on confirmed CARs: State or territory of record* State or territory of patient residence CAR name CAR type Organism name (genus and species) Date of collection Facility type Patient age range. Date of confirmation Confirming laboratory name * In the first instance, this refers to the state or territory in which the hospital is located. Where this information has not been entered, or if the source of the isolate is from the community, this refers to the patient’s state or territory of residence. Further detail about the CARAlert operational model is provided in Appendix 2. CARAlert standard operating procedures 5
Critical antimicrobial resistances reported through CARAlert The organisms reported through CARAlert are drawn from the list of high-priority organisms and antimicrobials that are the focus of the AURA Surveillance System. The scope of organisms and CARs are regularly reviewed, based on the latest evidence on CARs that emerge in Australia and overseas. The most recent review, undertaken in 2018, resulted in the addition of four new CARs reported through CARAlert. From 1 January 2019, the CARs listed in Table 1 are reported to CARAlert. Table 1: Critical antimicrobial resistances for reporting to CARAlert Species Critical resistance (from January 2019) Acinetobacter baumannii complex Carbapenemase-producing* Candida auris* – Carbapenemase-producing, and/or ribosomal methyltransferase- Enterobacterales producing Transmissible colistin resistance* Enterococcus species Linezolid resistant Mycobacterium tuberculosis Multidrug-resistant (resistant to at least rifampicin and isoniazid) Neisseria gonorrhoeae Ceftriaxone non-susceptible or azithromycin non-susceptible Salmonella species Ceftriaxone non-susceptible Shigella species Multidrug-resistant Staphylococcus aureus complex† Vancomycin, linezolid or daptomycin non-susceptible Streptococcus pyogenes Penicillin reduced susceptibility Pseudomonas aeruginosa Carbapenemase-producing* * If the specimen with a confirmed CAR was collected in 2019, it can be submitted retrospectively † For CARAlert, S. aureus complex includes S. argenteus and S. schweitzeri Intended use of data collected through CARAlert The data generated through CARAlert is not intended for use in epidemiological analyses. Rather, the information collected through CARAlert allows health service providers, laboratories, public health units and policymakers at local, state and territory, and national levels to receive timely reports and analyses of national data that complement current local reporting to the providers of patient care. In addition, regular reports, with analyses, are made available on the Commission’s website. Since October 2016, secure access to the CARAlert system has enabled designated state and territory health personnel to view records for their own jurisdiction at any time. The available information includes the name of the public hospital where the patient who had the infection was being cared for, at the time the specimen was collected. This enables timely monitoring of the geographic distribution of CARs, and liaison with hospitals, as appropriate, to confirm that infection control action has been taken in the event of an outbreak. These authorities can also generate their own reports from CARAlert. It is intended that states and territories will use this data to identify local issues, and respond to potential and proven multi-site outbreaks of CARs. Laboratory identification numbers are included in all reports submitted through CARAlert, providing designated state and territory users with an opportunity to contact confirming laboratories directly for further information and/or to discuss potential outbreaks in their jurisdiction. Primary responsibility for clinical response to CARs lies with local health organisations, and state and territory health departments. Some states have made CARAlert standard operating procedures 6
carbapenemase-producing Enterobacterales (CPE) notifiable, and others have implemented local surveillance of CPE – CARAlert complements this local data. CARAlert standard operating procedures 7
Roles and responsibilities of stakeholders who provide data to CARAlert The effective operation of CARAlert relies on the cooperation and collaboration of a range of stakeholders. In order to ensure the effective operation of CARAlert, and the use of results from the system, the roles and responsibilities of stakeholders who provide data to CARAlert are outlined below. Originating laboratories The roles and responsibilities of originating laboratories relating to the CARAlert system are outlined below: Undertake the first routine testing of isolates Identify isolates that may have the potential to be a CAR Notify the requesting clinician of the test results, and the suspected CAR Send the suspected isolate to a confirming laboratory for confirmation, along with a CARAlert referral form. Preliminary results generated during initial testing must also be provided to the confirming laboratory Ensure the following details are included on the referral form as the confirming laboratory will be required to enter this information into CARAlert if a CAR is confirmed: - name of originating laboratory (laboratory reporting on first isolation) - specimen identifier (accession number allocated by the originating laboratory, required for tracking purposes) - date of specimen collection - date specimen referred - organism name (genus and species) - clinical isolate or screen - specimen type (blood, urine, wound, screen, other) - facility type (hospital, aged care home, other, unknown), where the specimen was collected - if facility type is a hospital, name of hospital - patient demographic data – date of birth, sex and postcode of patient’s residence (for an overseas patient, record as ‘9999’). Note: Date of birth is converted to an age range, prior to transmission to the CARAlert system. In some cases, the originating laboratory may also be the confirming laboratory, where the necessary tests can be undertaken and the results entered into CARAlert. These laboratories are required to register with the Commission to gain access to CARAlert. The information can be provided to the confirming laboratory by completing the CARAlert Isolate Referral Form and including it with the isolate. A copy of the CARAlert Isolate Referral Form can be found on the Commission’s AURA website. Confirming laboratories The roles and responsibilities of confirming laboratories relating to the CARAlert system are outlined below: Receive isolates from originating laboratories for confirmation of a CAR Undertake the necessary confirmatory tests for a CAR CARAlert standard operating procedures 8
Notify the originating laboratory of test outcomes through the usual communication channels, regardless of whether a CAR is confirmed or not Once an isolate has been confirmed as a CAR, and after the originating laboratory has been notified, enter data into the CARAlert web-portal. This includes data provided from the originating laboratory: - name of originating laboratory (laboratory reporting on first isolation) - specimen identifiers (accession numbers allocated by the originating laboratory and confirming laboratories, required for tracking purposes) - date of specimen collection - date specimen referred - organism name (genus and species) - clinical isolate or screen - specimen type (blood, urine, wound, screen, other) - facility type (hospital, residential aged care facility, other, unknown), where the specimen was collected - if facility type is a hospital, name of hospital - patient demographic data – date of birth, sex and postcode of patient’s residence (for an overseas patient, record as ‘9999’). Note: Date of birth is converted to an age range prior to transmission to the CARAlert system. Confirming laboratories must also enter the following additional information on CARs: - name of confirming laboratory (laboratory confirming CAR) - date of confirmation - CARs - type or subtype if known or relevant (e.g. IMP, IMP-4). Subtyping can occur outside the five working day window. Store all confirmed CAR isolates according to usual standard operating protocol. CARAlert standard operating procedures 9
Roles and responsibilities of state and territory contacts with designated access to data from the CARAlert system The roles and responsibilities of the contacts from state and territory health departments with designated access to data from the CARAlert system include: Review of the detailed information available to designated officers through the CARAlert system web portal, and the information on confirmed CARs provided in the weekly summary reports Use this information to liaise with relevant personnel to obtain further detail, and if required, commence jurisdictional investigation. This will assist in guiding/supporting any actions that may be required in response to the CAR(s) identified in their jurisdiction. This may include informing relevant personnel in facilities where CARs have been identified, or providing them with targeted infection prevention and control information, or other supports to minimise risk of transmission Subject to jurisdictional governance arrangements, coordinate communication with health services within their jurisdiction and other jurisdictions where patient transfers are known to have occurred, to prevent further spread of infection Provide health services with additional information to assist in the monitoring and management of confirmed CARs within their facilities and to provide guidance on infection prevention and control strategies and antimicrobial responses where necessary Subject to jurisdictional governance arrangements, in the event of an outbreak, coordinate/support actions to identify transmission pathways and implement strategies to control the spread of the CAR(s) Provide information and advice to health services on infection prevention and control issues related to the specific CARs as required It is noted that a number of the states and territories have complementary reporting processes in place for some resistances (e.g. CPE) and may utilise the results available through CARAlert differently in those cases. However, the important role of CARAlert in identifying potential outbreaks remains of value. CARAlert standard operating procedures 10
Roles and responsibilities of other users of data from the CARAlert system Some of the roles and responsibilities of other stakeholders with access to data from the CARAlert system are outlined below. Clinicians Receive timely information on confirmed CARs from the originating laboratory, through usual notification processes. Keep up to date with the findings of the latest CARAlert data updates and annual summary reports published on the Commission’s AURA website – and where appropriate, use this information to improve local knowledge and awareness of critical resistances and support appropriate antimicrobial prescribing. Health services Monitor confirmed CARs in their facilities and, where necessary, implement infection prevention and control strategies, and antimicrobial stewardship programs to prevent and/or minimise the impact of CAR transmission. Keep up to date with the findings of the latest CARAlert data updates and annual summary reports published on the Commission’s AURA website – and where appropriate, use this information to improve local knowledge and awareness of critical resistances and support appropriate antimicrobial prescribing. CARAlert standard operating procedures 11
Roles and responsibilities of the CARAlert manager – the Australian Commission on Safety and Quality in Health Care The AURA National Coordination Unit (NCU) has developed AURA and CARAlert and is responsible for ongoing coordination and management of these systems. Key responsibilities include: Identifying priority organisms for inclusion in reporting to CARAlert Providing information technology (IT) and procedural support in relation to the CARAlert System to originating and confirming laboratories, state and territory health departments and private facilities where CARs are confirmed, as required Analysis of CARAlert data and communication of the results of analyses Providing regular reports on analyses of trends in CARs through data updates and annual summary reports on the Commission’s AURA website The AURA NCU will provide regular reports on analyses of trends in CARs via the Commission’s AURA website. When a CAR is submitted through CARAlert by a confirming laboratory, an email with summary information is sent to designated AURA NCU officers. The record is reviewed for any unusual patterns in the data. CAR records are downloaded on a weekly basis from the CARAlert web portal and added to a master database by the clinical microbiologist, and held securely by the AURA NCU. The Commission’s clinical microbiologist regularly reviews the data for inconsistencies and possible duplicate entries. Records flagged for these reasons are checked directly with the confirming laboratory. If action is required, the AURA NCU notifies the relevant contracted system hosts and IT support organisation of the corrections required. Changes are made on a weekly basis; the Commission manages this communication. Final checks are made by the AURA NCU to ensure the changes were successful. If upon reviewing the records submitted to CARAlert, a potential outbreak is suspected, the clinical microbiologist will notify the Stream Director and senior medical advisor at the Commission. Contact will then be made with the relevant jurisdiction to clarify the local circumstances and response, as needed. CARAlert standard operating procedures 12
Appendix 1 CARAlert confirming laboratories, 2021 The Commission thanks all the originating and confirming laboratories for their support for CARAlert and AURA. The following confirming laboratories contributed to CARAlert in 2021: State or Territory Institution Australian Capital Territory ACT Pathology, Garran NSW Health Pathology, Concord Hospital, Concord NSW Health Pathology, Liverpool Hospital, Liverpool NSW Health Pathology, John Hunter Hospital, New Lambton Heights NSW Health Pathology, Royal North Shore Hospital, St Leonards New South Wales NSW Health Pathology, Royal Prince Alfred Hospital, Camperdown NSW Health Pathology, St George Hospital, Kogarah NSW Health Pathology, The Prince of Wales Hospital, Randwick NSW Health Pathology, Westmead Hospital, Westmead St Vincent's Pathology (SydPath), Darlinghurst Northern Territory Territory Pathology, Tiwi Pathology Queensland, Central laboratory, Royal Brisbane and Women’s Hospital, Herston Pathology Queensland, Forensic & Scientific Services, Coopers Plains Queensland QML Pathology, Murarrie Sullivan Nicolaides Pathology, Bowen Hills South Australia SA Pathology, Royal Adelaide Hospital, Adelaide Tasmania Royal Hobart Hospital, Hobart) Alfred Pathology Service, Melbourne Austin Pathology, Heidelberg Dorevitch Pathology, Heidelberg Microbiological Diagnostic Unit Public Health Laboratory, Melbourne Victoria Victorian Infectious Diseases Reference Laboratory (VIDRL), Melbourne Melbourne Pathology, Collingwood Monash Pathology, Clayton St Vincent's Hospital, Fitzroy PathWest Laboratory Medicine WA, Fiona Stanley Hospital, Murdoch Western Australia PathWest Laboratory Medicine WA, QEII Medical Centre, Nedlands Australian Clinical Labs, Osborne Park CARAlert standard operating procedures 13
Appendix 2 CARAlert alert process Figure 1: CARAlert operational model process STEP 1 – Detecting a possible CAR Possible CAR referred to confirming laboratory ORIGINATING LABORATORY All isolates accompanied by information Detects possible CAR and sends required by CARAlert in an appropriate request isolate for confirmation form STEP 2 – Confirmation CONFIRMING LABORATORY Molecular and/or phenotypic confirmation tests Undertakes molecular / phenotypic are done in a timely manner (no longer than five working days). Refer to Section 2: confirmatory testing Detection of CARs If not a confirmed CAR, the originating laboratory will be notified through normal communication channels If a CAR is confirmed, the confirming Yes No laboratory will notify the originating laboratory CAR and enter data items into the CARAlert web- confirmed? portal. STEP 3 – Notification to CARAlert NOTIFICATION Authorised Via secure access, a confirming laboratory enters confirmatory data items into CARAlert, TO CARAlert state and as listed in Section 1.6: Roles and Confirming territory users responsibilities of confirming laboratories and laboratory enters review CAR authorised state and territory health CAR data notifications department users Weekly Clinician Summary of STEP 4 – Weekly Summary of CARs CARs Following the completed entry of a CAR: Confirmed CAR Health service is automatically Information automatically populates the weekly populated into Summary of CARs which is circulated each Infection the Weekly Control Units Thursday to authorised Commission, state and territory health department and Australian Summary Government Department of Health users, and all confirming laboratories. State & territory health Bimonthly data updates and annual reports are REPORTS departments published on the Commission’s AURA website. Available from AURA website National bodies
Level 5, 255 Elizabeth Street, Sydney NSW 2000 GPO Box 5480, Sydney NSW 2001 Phone: (02) 9126 3600 Fax: (02) 9126 3613 Email: caralert@safetyandquality.gov.au Website: www.safetyandquality.gov.au
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